Material Compliance: Bridging the Gap Between Regulations and Customer Requirements

The landscape of material compliance has undergone a fundamental transformation in recent years. No longer limited to simple regulatory adherence, today's material compliance encompasses a complex web of requirements spanning products, packaging, and auxiliary materials. As organizations navigate this evolving terrain, they must balance increasing regulatory demands with growing customer expectations, creating a need for a more comprehensive approach to compliance management.

The Evolution of Material Compliance: A New Definition for Modern Times

Material compliance has evolved far beyond its traditional boundaries. As explained by Julian Rudat, sustainability consultant at seleon GmbH, it now "describes the adherence to all material related specifications that affect our products, but not the product alone." This expanded definition encompasses three key areas: the products themselves, their packaging, and the auxiliary materials used in production processes. The scope has expanded significantly from early regulations like REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and RoHS (Restriction of Hazardous Substances). It now also includes CMR substances through MDR, new substance-specific regulations for packaging (PPWR), and eco-design requirements. This expansion reflects the growing complexity of modern manufacturing and supply chains, requiring organizations to maintain unprecedented levels of material awareness and control.

With each new regulatory requirement and rising customer expectations, the scope of material compliance continues to grow. What once began with a few sets of rules has evolved into a strategic element of product development and corporate management. Compliance is no longer seen merely as an obligation, but as an integral part of sustainable business processes.

The Twin Forces Driving Change: Regulations and Customer Demands

Two primary forces are reshaping the material compliance landscape. First, regulatory affairs must track an increasingly complex web of substance regulations – ranging from traditional frameworks to new substance-specific requirements. Simultaneously, customer demands are becoming increasingly sophisticated. Healthcare institutions, for example, are now incorporating substance-specific requirements into their procurement criteria, often ahead of legislative mandates. This proactive approach by customers creates an additional layer of compliance requirements that organizations must address.

The multitude of regulatory and customer requirements drive an increased need for detailed information throughout the entire value chain. Organizations must now maintain comprehensive knowledge of both their product composition and the applicable regulations to ensure compliance.

Building a Future-Proof Compliance Framework

Implementing a robust material compliance framework requires a systematic approach. The five-step implementation process recommended by seleon includes:

1. Status Analysis: Conduct workshops to identify stakeholders from regulatory affairs, sales, and quality management. Assess existing processes in your quality management system and evaluate current systems for tracking substance-specific requirements and Bill of Materials (BOM).
2. Strategic Planning: Develop a clear roadmap based on workshop findings and determine where you want to take your compliance program.
3. Process Development: Begin with stakeholder interviews, review quality management systems, and establish a clear "gate" for material approval where requirements are matched to specific materials.
4. Systems Integration: Implement software solutions to track rapidly changing regulations (like REACH's bi-annual revisions) and match BOM with new requirements.
5. Continuous Assessment: Establish ongoing supplier assessment processes, track certificates of conformity, and maintain current declarations of conformity for your products. As emphasized in the presentation, this is not a process that you perform once a time but rather a continuous improvement journey.

Key to success is the involvement of stakeholders from various departments, including regulatory affairs, sales, quality management, and R&D. This cross-functional approach ensures comprehensive coverage of all compliance aspects.

Beyond Compliance: Strategic Benefits and Competitive Advantages

Effective material compliance management offers benefits beyond mere regulatory adherence. Organizations can achieve:

• Enhanced market access through demonstrated compliance
• Minimized risks through improved supplier assessment
• Strengthened supplier relationships through better communication
• Development control leading to unique selling points
• Improved internal communication across departments

These advantages position material compliance as a strategic asset rather than just a regulatory burden, enabling organizations to differentiate themselves in the market. Seleon GmbH will be happy to help you unlock these benefits – with the implementation process described above and their market experience.

Conclusion

Material compliance has evolved into a complex, continuous journey that requires ongoing attention and resources. Success demands a systematic approach that addresses both regulatory requirements and customer expectations while delivering strategic benefits to the organization. By implementing a comprehensive framework and maintaining vigilance over changing requirements, organizations can turn compliance challenges into competitive advantages. The key lies in viewing material compliance not as a burden, but as an opportunity for business improvement and market differentiation.

Editorial notice:
This article is based on the corresponding presentation by seleon GmbH and speaker Julian Rudat during the MedtecLIVE Innovation Expo 2025 and was created with the support of AI. The supporting programme for MedtecLIVE 2026, which will take place in Stuttgart from 5 to 7 May 2026, also offers numerous presentations. The trade fair brings together suppliers, developers and manufacturers of medical technology, OEMs, distributors and other players in the medical technology community.